The Efficacy and Safety of Tigecycline for the Treatment of Complicated Intra‐Abdominal Infections: Analysis of Pooled Clinical Trial Data

Abstract

This pooled analysis includes 2 phase 3, double-blind trials designed to evaluate the safety and efficacy of tigecycline, versus that of imipenem-cilastatin, in 1642 adults with complicated intra-abdominal infections. Patients were randomized to receive either tigecycline (initial dose of 100 mg, followed by 50 mg intravenously every 12 h) or imipenem-cilastatin (500/500 mg intravenously every 6 h) for 5-14 days. The primary end point was the clinical response at the test-of-cure visit (12-42 days after therapy) in the co-primary end point microbiologically evaluable and microbiological modified intent-to-treat populations. For the microbiologically evaluable group, clinical cure rates were 86.1% (441/512) for tigecycline, versus 86.2% (442/513) for imipenem-cilastatin (95% confidence interval for the difference, -4.5% to 4.4%; P < .0001 for noninferiority). Clinical cure rates in the microbiological modified intent-to-treat population were 80.2% (506/631) for tigecycline, versus 81.5% (514/631) for imipenem-cilastatin (95% confidence interval for the difference, -5.8% to 3.2%; P < .0001 for noninferiority). Nausea (24.4% tigecycline, 19.0% imipenem-cilastatin [P = .01]), vomiting (19.2% tigecycline, 14.3% imipenem-cilastatin [P = .008]), and diarrhea (13.8% tigecycline, 13.2% imipenem-cilastatin [P = .719]) were the most frequently reported adverse events. This pooled analysis demonstrates that tigecycline was efficacious and well tolerated in the treatment of patients with complicated intra-abdominal infections.

Pharmacokinetic/pharmacodynamic (PK/PD) considerations in the management of Gram-positive bacteraemia

“…The presence of a modified side chain on tigecycline, with respect to minocycline, circumvents resistance mechanisms that plague tetracycline and other antibiotics in this class. Tigecycline has been evaluated for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and pneumonia [82][83]. In vitro, tigecycline is characterized by time-dependent activity against S. pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae [84][85][86].…”

An Evaluation of the Effectiveness of Risk Minimization Measures for Tigecycline in the European Union

“…Adjudication of potential cases of superinfection and lack of efficacy allowed for objective assessments of these endpoints. Moreover, compared with clinical trials, this study provides an estimate of superinfection and lack of efficacy rates in a patient population with a greater number of comorbidities, higher illness severity scores, and a higher proportion of resistant organisms [19], more closely mirroring the population using tigecycline in clinical practice.…”

Clostridium tertium Bacteremia in a Non-neutropenic Patient with Small Bowel Obstruction

“…Tigecycline was used to successfully treat patients with complicated intra-abdominal infections in several studies [16,17]. Tigecycline is not significantly toxic and has a wide spectrum Figure 3.…”